{"id":39671,"date":"2026-10-02T10:22:00","date_gmt":"2026-10-02T14:22:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39671"},"modified":"2026-09-21T17:36:32","modified_gmt":"2026-09-21T21:36:32","slug":"the-state-drug-affordability-board-is-watching-patent-listings-you-havent-checked-in-a-year","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/the-state-drug-affordability-board-is-watching-patent-listings-you-havent-checked-in-a-year\/","title":{"rendered":"The State Drug Affordability Board Is Watching Patent Listings You Haven’t Checked in a Year"},"content":{"rendered":"\n
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On July 1, 2026, a federal judge in Denver blocked Colorado’s price cap on Enbrel. The board that set the cap had spent more than four years on the case. The order that stopped it turned on one question: does Enbrel still carry active, enforceable US patents. It does. That single fact, not the $31,000 annual price tag or the affordability math behind it, is why Colorado’s cap is on hold.[1][2]<\/sup><\/p>\n\n\n\n

State prescription drug affordability boards (PDABs) now operate in nine to eleven states, depending on which tracker you use and how it counts an inactive board.[11][12][13]<\/sup> Four of those states, Colorado, Maryland, Minnesota and Washington, can set an upper payment limit (UPL): a hard cap on what purchasers and payers must pay for a drug the board has ruled unaffordable.[9][10]<\/sup> Every one of those caps rests on an assumption boards have not had to test carefully until now: that a drug’s patent status will not undo the cap before it takes effect. Colorado just found out otherwise.<\/p>\n\n\n\n

The Short Answer<\/h2>\n\n\n\n

Whether a drug still carries listed, unexpired US patents now determines whether a state upper payment limit can survive in federal court, whether a board’s affordability review will still matter by the time the board finishes it, and whether a manufacturer’s own transparency filings already contain the patent data a board needs. Colorado’s Enbrel cap was preliminarily enjoined in July 2026 on patent-preemption grounds. Maryland’s caps on Jardiance and Ozempic, both drugs with no generic competitor expected before the 2030s, have not yet faced that argument in court. Maryland’s board also nearly capped Farxiga days before a generic entered the market and made the cap pointless. None of this required new legislation to see coming. It required someone at each board, or at each manufacturer being reviewed, to check the Orange Book on a regular cadence instead of once at the start of a review that can take years.<\/p>\n\n\n\n

Nine Findings Worth Citing on Their Own<\/h2>\n\n\n\n
    \n
  1. A federal district court in Colorado issued a preliminary injunction on July 1, 2026, blocking the state’s upper payment limit on Enbrel, on the ground that federal patent law preempts state price caps on patented drugs.[1][2]<\/sup><\/li>\n\n\n\n
  2. The injunction rests on a single 2007 Federal Circuit precedent, Biotechnology Industry Organization v. District of Columbia<\/em>, which struck down a Washington, D.C. law penalizing excessive prices on patented drugs.[2][7]<\/sup><\/li>\n\n\n\n
  3. Colorado’s Enbrel case took more than four years from the board’s first vote (February 2024) to the injunction (July 2026), during which Amgen filed two separate federal lawsuits.[3][4][5]<\/sup><\/li>\n\n\n\n
  4. Four states, Colorado, Maryland, Minnesota and Washington, currently have UPL authority; as of mid-2026 only Colorado and Maryland have used it.[9][10][11]<\/sup><\/li>\n\n\n\n
  5. Maryland’s board voted to cap Farxiga in early 2026, then reversed course because the FDA approved the drug’s first generic days before the board’s decision.[14]<\/sup><\/li>\n\n\n\n
  6. The FTC has run three rounds of Orange Book patent listing challenges since November 2023, disputing more than 600 patent listings across roughly 20 brand-name products, and reports delistings across 22 products after the first two rounds alone.[16][25][27][29]<\/sup><\/li>\n\n\n\n
  7. A Federal Circuit ruling in December 2024, Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals<\/em>, ordered Teva to delist five device patents from its ProAir HFA inhaler, the first appellate ruling on whether inhaler-device patents belong in the Orange Book at all.[26][28]<\/sup><\/li>\n\n\n\n
  8. At least 21 states already require manufacturers to report a drug’s patent expiration date as part of routine price transparency filings, a data field several boards have not systematically cross-referenced against their own review targets.[31][33]<\/sup><\/li>\n\n\n\n
  9. Novo Nordisk’s core semaglutide patent expired in several countries in March 2026, but secondary formulation, device and dosing patents are expected to keep US generic entry off the market until at least 2031 or 2032, well past Maryland’s January 2027 Ozempic cap date.[34][35][36]<\/sup><\/li>\n<\/ol>\n\n\n\n

    The Board Count Problem: Why Trackers Disagree<\/h2>\n\n\n\n

    Ask how many states have a prescription drug affordability board and you will get three different answers depending on when the question was asked and what counts. Families USA’s April 2026 fact sheet counts seven states with existing boards, four of them holding UPL authority.[10]<\/sup> A December 2025 MultiState brief counts nine, with the same four holding UPL authority.[12]<\/sup> A 2024 Stateline analysis, still widely cited, counts eleven, including boards in Ohio and New Hampshire alongside nine Democratic-led states.[13]<\/sup><\/p>\n\n\n\n

    The gap is not a reporting error. It reflects three separate facts on the ground: some boards have been created by statute but not funded or staffed, some have quietly stopped meeting, and some states use a different name (Oregon and Washington call theirs by variations on “affordability board” while New Jersey’s operates under a broader transparency-and-affordability statute).[10][12][13]<\/sup> A tracker built in 2024 and never updated will overstate the count today. That is the same problem, one level up, that this piece is about: a list that was accurate on the day someone compiled it degrades every month it goes unchecked.<\/p>\n\n\n\n

    The Four States With Teeth<\/h3>\n\n\n\n

    Colorado, Maryland, Minnesota and Washington can set an upper payment limit once their board completes a cost review and votes a drug “unaffordable.” Colorado was first to actually set one, on Enbrel, following a rulemaking that closed in October 2025.[8][10]<\/sup> Maryland followed with two UPLs in the space of two months: Jardiance in April 2026, capped at $204 for a 30-day supply beginning January 2027, and Ozempic in May 2026, capped at $274 for a 30-day supply on the same effective date.[14]<\/sup> Both Maryland figures were pegged to the Medicare maximum fair price negotiated under the Inflation Reduction Act, the same benchmark Colorado used for Enbrel.[14][15]<\/sup> Washington and Minnesota spent 2025 building review infrastructure and had not yet issued a UPL as of early 2026.[13][15]<\/sup><\/p>\n\n\n\n

    State<\/th>UPL authority granted<\/th>First UPL drug<\/th>Cap<\/th>Effective date<\/th>Source<\/th><\/tr>
    Colorado<\/td>2021<\/td>Enbrel (etanercept)<\/td>~$600\/weekly dose (~$31,000\/year)<\/td>Enjoined before Jan 2027 start<\/td>[1][8]<\/td><\/tr>
    Maryland<\/td>2024 (expanded 2026)<\/td>Jardiance (empagliflozin)<\/td>$204\/30-day supply<\/td>January 2027<\/td>[14]<\/td><\/tr>
    Maryland<\/td>2024 (expanded 2026)<\/td>Ozempic (semaglutide)<\/td>$274\/30-day supply<\/td>January 2027<\/td>[14]<\/td><\/tr>
    Minnesota<\/td>Yes<\/td>None issued as of early 2026<\/td>\u2014<\/td>\u2014<\/td>[13][15]<\/td><\/tr>
    Washington<\/td>Yes<\/td>None issued as of early 2026<\/td>\u2014<\/td>\u2014<\/td>[13][15]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Patent Status, Not Price Math, Decided Colorado’s First UPL<\/h2>\n\n\n\n

    Colorado’s board voted Enbrel “unaffordable for Colorado consumers” on February 16, 2024, then voted a week later to begin rulemaking on a cap.[6]<\/sup> Enbrel’s list price has climbed more than 1,500 percent since 1998, a figure the board cited as evidence of the affordability problem it exists to address.[2]<\/sup><\/p>\n\n\n\n

    \n

    Enbrel’s list price has risen more than 1,500 percent since 1998. That single statistic anchored Colorado’s case for capping the drug, and it is the kind of number a board can gather in an afternoon. Whether the drug’s patents were still enforceable took four years to sort out in federal court.[2]<\/sup><\/p>\n<\/blockquote>\n\n\n\n

    Amgen, Enbrel’s manufacturer, sued twice. The first suit, filed in March 2024 before any cap existed, argued the PDAB statute was preempted by federal patent law and Medicare law and violated the Constitution’s Supremacy and Commerce clauses.[3][5]<\/sup> A district court dismissed it in March 2025 for lack of standing, ruling the case premature since no cap had actually been set yet.[4]<\/sup> Amgen appealed, but once Colorado’s board formally established the Enbrel UPL in October 2025, Amgen filed a second suit and the parties jointly dismissed the pending appeal in January 2026 as moot.[3]<\/sup><\/p>\n\n\n\n

    The second suit produced the July 2026 injunction. The court’s reasoning traced back to a single 2007 decision: Biotechnology Industry Organization v. District of Columbia<\/em>, in which the Federal Circuit struck down a D.C. law that penalized excessive pricing of patented drugs, holding that a law “targeted at the patent right,” reaching only patented products, conflicts with the balance Congress struck in the Patent Act.[7]<\/sup> The Colorado court read that precedent as binding and rejected the state’s argument that a UPL only regulates downstream purchasers rather than the manufacturer directly.[2]<\/sup><\/p>\n\n\n\n

    Timeline: Enbrel From “Unaffordable” to Injunction<\/h3>\n\n\n\n
    Date<\/th>Event<\/th>Source<\/th><\/tr>
    Feb. 16, 2024<\/td>Board votes Enbrel unaffordable for Colorado consumers<\/td>[6]<\/td><\/tr>
    Feb. 23, 2024<\/td>Board votes to select Enbrel for UPL rulemaking<\/td>[6]<\/td><\/tr>
    March 2024<\/td>Amgen files first federal lawsuit (preemption, Supremacy Clause, Commerce Clause)<\/td>[5]<\/td><\/tr>
    March 28, 2025<\/td>District court dismisses first suit; Amgen lacks standing, claim premature<\/td>[4]<\/td><\/tr>
    Oct. 1\u20133, 2025<\/td>Board’s rulemaking hearings on draft Rule 4.3, Enbrel UPL<\/td>[8]<\/td><\/tr>
    Oct. 2025<\/td>Board formally establishes UPL for Enbrel<\/td>[3]<\/td><\/tr>
    Oct. 30, 2025<\/td>Amgen files second federal lawsuit<\/td>[3][9]<\/td><\/tr>
    Jan. 2026<\/td>Parties jointly dismiss the first suit’s pending appeal as moot<\/td>[3]<\/td><\/tr>
    July 1, 2026<\/td>Court grants preliminary injunction on patent-preemption grounds<\/td>[1][2]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Maryland’s Two Caps Look Safer Today. That Could Change.<\/h2>\n\n\n\n

    Maryland set upper payment limits on Jardiance and Ozempic within weeks of Colorado’s injunction, using the same Medicare maximum fair price benchmark Colorado had used for Enbrel.[14]<\/sup> Neither cap has drawn an Amgen-style lawsuit yet. The reason may simply be timing: Colorado’s fight took four years to reach a ruling, and Maryland’s caps do not take effect until January 2027.<\/p>\n\n\n\n

    Ozempic’s Patent Runway Extends Well Past Maryland’s Cap Date<\/h3>\n\n\n\n

    Novo Nordisk’s foundational semaglutide compound patent, filed in 2006, expired in several countries in March 2026, triggering immediate generic launches in markets like India.[35]<\/sup> The company’s US exclusivity is a different story. A 2024 settlement with Mylan is expected to allow that generic manufacturer to launch some strengths of semaglutide only in the second half of 2031 or first half of 2032, and industry analysts expect Novo Nordisk’s broader US patent protection, built on formulation, device and dosing patents layered on top of the core compound claim, to hold until at least 2032.[34][36]<\/sup> Canada’s exclusivity lapsed in January 2026 after Novo Nordisk missed a maintenance-fee deadline, an accident of patent administration rather than a deliberate expiration, and one that has no US analog on the public record.[34]<\/sup><\/p>\n\n\n\n

    That gap matters for one reason: the Colorado ruling turned entirely on whether Enbrel still carried enforceable US patents. Ozempic does, by a wide margin, active US patents that will still be in force in January 2027 when Maryland’s cap is due to take effect. If Novo Nordisk brings the same preemption argument Amgen brought, using the same 2007 precedent, Maryland’s board will be arguing the identical legal question Colorado just lost, on a drug with a clearer, longer patent runway than Enbrel had.<\/p>\n\n\n\n

    Jardiance: Same Exposure, Different Manufacturer<\/h3>\n\n\n\n

    Jardiance (empagliflozin), jointly marketed by Boehringer Ingelheim and Eli Lilly, has no FDA-approved generic competitor as of 2026.[23]<\/sup> That places it in the same category as Ozempic for preemption purposes: an active-patent drug subject to a state price cap that has not yet been tested against the Colorado precedent.<\/p>\n\n\n\n

    Farxiga: The UPL That Generic Entry Made Moot<\/h3>\n\n\n\n

    Maryland’s board also considered Farxiga (dapagliflozin) for a UPL in its April 2026 meeting and, according to industry coverage of the meeting, decided against it because the FDA had approved the drug’s first generic just days earlier.[14]<\/sup> The timing was tight enough to be worth stating precisely: AstraZeneca’s primary US patent on dapagliflozin expired April 4, 2026, and the FDA approved multiple generic dapagliflozin applications on April 7, 2026.[22][25]<\/sup> DrugPatentWatch’s own patent-tracking data on Farxiga lists seventeen US patents and four FDA regulatory exclusivities associated with the product, illustrating why a single expiration date rarely settles a generic-entry question on its own; boards and manufacturers alike need the full patent family, not just the headline compound patent, to know when a cap decision will actually matter.[37]<\/sup> Maryland’s own PDAB chair, Van Mitchell, has publicly pointed to the Farxiga episode as a symptom of how slow-moving the board’s process can be relative to how fast a patent portfolio’s status can change.[14]<\/sup><\/p>\n\n\n\n

    Drug<\/th>Manufacturer<\/th>Board action<\/th>US generic\/biosimilar status<\/th>Preemption exposure (analysis)<\/th><\/tr>
    Enbrel<\/td>Amgen<\/td>UPL set, then enjoined<\/td>No biosimilar substitution at retail; patents still active<\/td>Confirmed: enjoined on this basis<\/td><\/tr>
    Jardiance<\/td>Boehringer Ingelheim \/ Eli Lilly<\/td>UPL set, effective Jan. 2027<\/td>No FDA-approved generic[23]<\/sup><\/td>Untested, same category as Enbrel<\/td><\/tr>
    Ozempic<\/td>Novo Nordisk<\/td>UPL set, effective Jan. 2027<\/td>US generic not expected before 2031\u20132032[34][36]<\/sup><\/td>Untested, longer patent runway than Enbrel<\/td><\/tr>
    Farxiga<\/td>AstraZeneca<\/td>UPL considered, not adopted<\/td>First generic approved April 7, 2026[25]<\/sup><\/td>Moot: review overtaken by generic entry<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    The last column above is analysis, not a reported legal conclusion; no court has ruled on Jardiance or Ozempic. It follows directly from the reasoning a federal court already applied to Enbrel: a UPL on a drug that still carries active, enforceable US patents is exposed to the same preemption argument, regardless of which state board issued it or which company holds the patents.<\/p>\n\n\n\n

    The FTC Has Been Running a Parallel Campaign Since 2023<\/h2>\n\n\n\n

    While state boards were building affordability-review infrastructure, the FTC was pursuing a separate but related fight over what belongs in the Orange Book in the first place. Unlike a PDAB, which sets a price ceiling, the FTC’s tool is a patent listing dispute: a formal challenge, under FDA regulations, arguing that a patent does not meet the statutory criteria for Orange Book listing and should be delisted so that generic competition is not delayed by an automatic 30-month litigation stay that a listed patent can trigger under the Hatch-Waxman Act.[30]<\/sup><\/p>\n\n\n\n

    Round<\/th>Date<\/th>Scope<\/th>Result<\/th>Source<\/th><\/tr>
    1<\/td>November 2023<\/td>100+ patents, 10 companies; asthma inhalers, epinephrine autoinjectors, Restasis bottles<\/td>Kaleo, Impax, GSK, Glaxo Group delisted patents in response<\/td>[16][27]<\/td><\/tr>
    2<\/td>April 30, 2024<\/td>300+ patents, 20 brand products; diabetes, obesity, asthma, COPD injectors and inhalers<\/td>Delistings across 22 brand products combined with round 1<\/td>[27][29]<\/td><\/tr>
    3<\/td>May 21, 2025<\/td>200+ patents, 5 companies; renewed challenges to previously-disputed listings<\/td>Follows Federal Circuit affirmance in Teva v. Amneal<\/td>[25]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Teva v. Amneal: The Question FDA Wouldn’t Answer<\/h3>\n\n\n\n

    For years, the FDA declined to say whether patents covering the device components of a combination product, an inhaler’s dose counter, for example, rather than the drug itself, belong in the Orange Book at all.[21][30]<\/sup> That question reached the Federal Circuit in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC<\/em>, No. 2024-1936, over five patents Teva had listed for its ProAir HFA metered-dose inhaler.[19][28]<\/sup> Amneal, seeking approval for a generic version, argued the patents covered only the inhaler device and not the drug, and should be delisted; the FTC filed an amicus brief backing that view.[20]<\/sup> On December 20, 2024, the Federal Circuit affirmed a district court order compelling Teva to delist all five patents.[26][28]<\/sup><\/p>\n\n\n\n

    The FTC treated the ruling as vindication of its broader campaign and cited it directly in its May 2025 round of renewed challenges against other manufacturers’ device patents.[25]<\/sup> The practical effect for anyone tracking a brand product’s competitive timeline: a patent’s presence in the Orange Book is no longer a reliable signal of its enforceability on its own. A listed patent can be under active dispute, can have already lost in litigation for a different product in the same class, or can be delisted with no public announcement beyond the database update itself.<\/p>\n\n\n\n

    The Data Boards Already Have and Have Not Fully Used<\/h2>\n\n\n\n

    Separately from PDAB and FTC activity, at least 21 states operate drug price transparency laws requiring manufacturers to report data whenever a drug’s price rises past a set threshold.[31][33]<\/sup> A national analysis of these programs found that most already require manufacturers to disclose a drug’s patent expiration date alongside wholesale acquisition cost, length of time on market and other basic fields.[31]<\/sup> Oregon’s program explicitly feeds its transparency data into its own affordability board’s review process.[24][32]<\/sup><\/p>\n\n\n\n

    That overlap is not fully exploited. Transparency filings are typically triggered by a price increase, not organized as a running patent-status feed a board can query when selecting review targets. Farxiga’s April 2026 near-miss in Maryland is the clearest illustration: the information that would have flagged the incoming generic, an imminent patent expiration and pending ANDA approvals, existed in the public record well before the board’s meeting. It simply was not the thing anyone on the review calendar was checking that week.<\/p>\n\n\n\n

    What Happens Next<\/h2>\n\n\n\n

    Virginia passed new PDAB legislation in 2026, its third attempt in three years, this time under Governor Abigail Spanberger, with a provision capping the board at twelve UPLs a year between mid-2026 and 2029.[9][17]<\/sup> Maine’s board is separately positioned to gain UPL authority pending a gubernatorial decision.[10]<\/sup> Every new UPL statute inherits the same exposure Colorado’s did the day it is signed: a price cap on a drug with live, enforceable US patents is a target for the identical preemption argument, and as of mid-2026 that argument has already won once.<\/p>\n\n\n\n

    None of this makes UPLs unworkable. It changes what due diligence looks like before a board picks a target. A drug past its patent cliff, like Farxiga after April 2026, carries essentially no preemption exposure because there is no longer a patent-driven exclusivity for a cap to interfere with. A drug years from its last patent expiration, like Ozempic, carries the same exposure Enbrel did, on a longer clock. Boards that treat a drug’s patent and exclusivity status as a one-time check at the start of a multi-year review, rather than something to monitor the way they already monitor list price, are the ones most likely to spend years building a rule a single Federal Circuit citation can freeze.<\/p>\n\n\n\n

    Methodology<\/h2>\n\n\n\n

    This analysis draws on FTC press releases, federal court filings and rulings, state PDAB meeting summaries and board websites, congressional research service reports, FDA drug approval announcements, and industry patent-tracking data, including DrugPatentWatch’s own patent listings for Farxiga. Board counts (seven, nine or eleven states) are reported as published by each tracker, with the discrepancy itself treated as a finding rather than resolved to a single number, since no single authoritative registry of active PDABs currently exists. The classification of Jardiance and Ozempic as carrying unresolved preemption exposure is original analysis: it applies the legal reasoning a federal court used against Colorado’s Enbrel cap to two drugs that have not yet been the subject of equivalent litigation, based on their publicly reported patent and exclusivity timelines as of the drafting date. It is not a prediction of how any future case would be decided, and it does not account for arguments specific to each manufacturer or state statute that have not yet been raised in court.<\/p>\n\n\n\n

    Frequently Asked Questions<\/h2>\n\n\n\n

    What is a state prescription drug affordability board?<\/h3>\n\n\n\n

    A PDAB is a state-created body that reviews selected high-cost drugs to determine whether they create an affordability challenge for the state’s health system or for patients, and in some states can then set an upper payment limit on what purchasers and payers must pay.[18]<\/sup><\/p>\n\n\n\n

    How many states have a PDAB?<\/h3>\n\n\n\n

    Between seven and eleven, depending on the tracker and whether it counts boards that exist by statute but are inactive or unfunded.[10][12][13]<\/sup> Four states, Colorado, Maryland, Minnesota and Washington, currently have authority to set upper payment limits.[9][10]<\/sup><\/p>\n\n\n\n

    What is an upper payment limit?<\/h3>\n\n\n\n

    A UPL is a maximum reimbursement amount a state sets for a specific drug after determining it is unaffordable. It typically applies to state and local government purchasers first, with some states extending it to private payers over time.[18]<\/sup><\/p>\n\n\n\n

    Why was Colorado’s Enbrel price cap blocked?<\/h3>\n\n\n\n

    A federal district court found the cap preempted by federal patent law, applying a 2007 Federal Circuit precedent holding that state laws targeting the price of patented drugs specifically conflict with the balance Congress struck in the Patent Act.[2][7]<\/sup><\/p>\n\n\n\n

    Could the same argument block Maryland’s caps on Jardiance and Ozempic?<\/h3>\n\n\n\n

    No court has ruled on either drug. Both currently have active US patents and no FDA-approved generic competitor, which is the same fact pattern that led to the Enbrel injunction. Whether either manufacturer raises the same argument, and whether a court reaches the same conclusion, remains open.[23][34][36]<\/sup><\/p>\n\n\n\n

    What is the Orange Book, and why does the FTC keep disputing patents in it?<\/h3>\n\n\n\n

    The Orange Book is the FDA’s public list of approved drugs and the patents and exclusivities covering them. Only certain patent types qualify for listing by statute. The FTC argues that some manufacturers have listed device or formulation patents that do not meet that standard, delaying generic entry through an automatic 30-month litigation stay that follows a listed-patent lawsuit.[21][30]<\/sup><\/p>\n\n\n\n

    What happened in Teva v. Amneal?<\/h3>\n\n\n\n

    The Federal Circuit ruled in December 2024 that five of Teva’s device patents on its ProAir HFA inhaler did not belong in the Orange Book and ordered them delisted, the first appellate decision squarely addressing whether inhaler-device patents meet the statutory listing standard.[26][28]<\/sup><\/p>\n\n\n\n

    Do states already collect patent data on the drugs their boards review?<\/h3>\n\n\n\n

    Often yes, just not from the board itself. At least 21 states require manufacturers to report a drug’s patent expiration date as part of separate price transparency filings triggered by price increases, and Oregon explicitly routes that data to its affordability board.[24][31][32]<\/sup><\/p>\n\n\n\n

    What happened with Farxiga in Maryland?<\/h3>\n\n\n\n

    Maryland’s board considered a UPL on Farxiga in its April 2026 meeting, then did not proceed because the FDA had approved the drug’s first generic just days before the vote, making a state price cap unnecessary.[14][22][25]<\/sup><\/p>\n\n\n\n

    Does a drug losing its patent automatically lower its price?<\/h3>\n\n\n\n

    Not immediately, and not always by much on its own. A brand-name drug can carry multiple patents and regulatory exclusivities that expire on different dates, so a single patent expiration does not guarantee a generic can launch; Farxiga alone carried seventeen listed US patents and four regulatory exclusivities before its first generic reached the market.[37]<\/sup> Full price competition typically builds as additional generic manufacturers enter over subsequent months.[22]<\/sup><\/p>\n\n\n\n

    Key Takeaways<\/h2>\n\n\n\n
      \n
    • Colorado’s Enbrel upper payment limit was preliminarily enjoined on July 1, 2026, on federal patent-preemption grounds, after more than four years of board proceedings and two Amgen lawsuits.<\/li>\n\n\n\n
    • The preemption argument rests on a single 2007 Federal Circuit precedent, BIO v. District of Columbia<\/em>, and applies to any state price cap targeted specifically at a patented drug.<\/li>\n\n\n\n
    • Maryland’s Jardiance and Ozempic caps, both set for January 2027, apply to drugs with no FDA-approved US generic expected before the 2030s, the same fact pattern that triggered Colorado’s injunction.<\/li>\n\n\n\n
    • Maryland separately avoided setting a UPL on Farxiga only because the FDA approved its first generic days before the board’s scheduled vote.<\/li>\n\n\n\n
    • The FTC has run three rounds of Orange Book patent listing disputes since November 2023, covering more than 600 patent listings and resulting in delistings across at least 22 brand products.<\/li>\n\n\n\n
    • At least 21 states already require manufacturers to report patent expiration dates through separate price transparency laws, data that is not yet systematically cross-referenced against PDAB review targets in most states.<\/li>\n<\/ul>\n\n\n\n

      References<\/h2>\n\n\n\n
        \n
      1. Colorado Sun. “Judge blocks Colorado price cap on the prescription drug Enbrel.” July 2, 2026. https:\/\/coloradosun.com\/2026\/07\/02\/pdab-enbrel-price-cap-injunction\/<\/li>\n\n\n\n
      2. The Conversation. “Colorado was the first state to cap a drug’s price \u2013 then a federal court stepped in.” July 2026. https:\/\/theconversation.com\/colorado-was-the-first-state-to-cap-a-drugs-price-then-a-federal-court-stepped-in-287043<\/li>\n\n\n\n
      3. Congressional Research Service. “Litigation over State Attempts to Lower Drug Costs: Prescription Drug Affordability Boards (PDABs).” LSB11390. Congress.gov. https:\/\/www.congress.gov\/crs-product\/LSB11390<\/li>\n\n\n\n
      4. Manatt, Phelps & Phillips, LLP. “Amgen Lawsuit Against Colorado PDAB Dismissed.” https:\/\/www.manatt.com\/insights\/insight\/amgen-lawsuit-against-colorado-pdab-dismissed<\/li>\n\n\n\n
      5. Colorado Sun. “Amgen sues Colorado prescription drug board over Enbrel price cap.” March 25, 2024. https:\/\/coloradosun.com\/2024\/03\/25\/amgen-lawsuit-enbrel-pdab\/<\/li>\n\n\n\n
      6. Colorado Bioscience Association. “Weekly Policy Blog: Amgen Lawsuit Asserts Colorado PDAB is Unconstitutional.” April 1, 2024. https:\/\/cobioscience.com\/weekly-policy-blog-amgen-lawsuit-asserts-colorado-pdab-is-unconstitutional\/<\/li>\n\n\n\n
      7. FindLaw. “Pharmaceutical Research and Manufacturers of America v. District of Columbia” (2007). https:\/\/caselaw.findlaw.com\/court\/us-federal-circuit\/1396804.html<\/li>\n\n\n\n
      8. Colorado Division of Insurance. “Draft Proposed Rule 4.3 Upper Payment Limit for Enbrel (Etanercept), Written Testimonies.” October 1, 2025. https:\/\/doi.colorado.gov\/sites\/doi\/files\/documents\/October%203%20UPL%20Written%20Testimonies.pdf<\/li>\n\n\n\n
      9. MultiState. “Prescription Drug Affordability Boards Face Legal Challenges as States Tackle Drug Costs.” February 25, 2026. https:\/\/www.multistate.us\/insider\/2026\/2\/25\/prescription-drug-affordability-boards-face-legal-challenges-as-states-tackle-drug-costs<\/li>\n\n\n\n
      10. Families USA. “PDABs 1 Pager 2026 Update Fact Sheet.” April 2026. https:\/\/www.familiesusa.org\/wp-content\/uploads\/2026\/04\/PDABs-1-Pager_2026-Update_Fact-Sheet-1.pdf<\/li>\n\n\n\n
      11. Rare Access Action Project. “Follow the Upper Payment Limit.” 2026. https:\/\/www.rareaccessactionproject.org\/state-policies\/pdab\/follow-the-upper-payment-limit\/<\/li>\n\n\n\n
      12. MultiState. “Here’s What Prescription Drug Affordability Boards Have Been Doing in 2025.” December 15, 2025. https:\/\/www.multistate.us\/insider\/2025\/12\/15\/heres-what-prescription-drug-affordability-boards-have-been-doing-in-2025-upls-affordability-reviews-and-expanded-authority<\/li>\n\n\n\n
      13. Washington State Standard \/ Stateline. “Angry patients spur new state watchdogs to bring down drug prices.” July 16, 2024. https:\/\/washingtonstatestandard.com\/2024\/07\/16\/angry-patients-spur-new-state-watchdogs-to-bring-down-drug-prices\/<\/li>\n\n\n\n
      14. Partnership for Safe Medicines. “Prescription Drug Affordability Board Activity, April-May 2026.” June 5, 2026. https:\/\/www.safemedicines.org\/2026\/06\/pdab-activity-apr-may-2026.html<\/li>\n\n\n\n
      15. Partnership for Safe Medicines. “Prescription Drug Affordability Board Activity, February-March 2026.” April 22, 2026. https:\/\/www.safemedicines.org\/2026\/04\/pdab-activity-feb-mar-2026.html<\/li>\n\n\n\n
      16. DLA Piper. “FTC continues to scrutinize Orange Book patent listings.” 2024. https:\/\/www.dlapiper.com\/en\/insights\/publications\/2024\/05\/ftc-continues-to-scrutinize-orange-book-patent-listings<\/li>\n\n\n\n
      17. Virginia LIS. “HB1724 – 2025 Regular Session.” https:\/\/lis.virginia.gov\/bill-details\/20251\/HB1724<\/li>\n\n\n\n
      18. Maryland Prescription Drug Affordability Board. “Upper Payment Limits.” https:\/\/pdab.maryland.gov\/upper-payment-limits<\/li>\n\n\n\n
      19. Knobbe Martens. “Teva v. Amneal oral arguments and claim construction order.” 2024. https:\/\/www.knobbe.com\/blog\/teva-v-amneal-oral-arguments-and-claim-construction-order-recent-developments-in-the-ongoing-debate-over-the-orange-book-listing-of-device-patents\/<\/li>\n\n\n\n
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      22. U.S. Food and Drug Administration. “FDA Approves First Generic Dapagliflozin Tablets.” April 7, 2026. https:\/\/www.fda.gov\/drugs\/drug-alerts-and-statements\/fda-approves-first-generic-dapagliflozin-tablets<\/li>\n\n\n\n
      23. Network Health. “Generic Farxiga (Dapagliflozin) Prices Are Dropping.” May 2026. https:\/\/networkhealth.com\/grow-in-the-know\/2026\/05\/generic-farxiga-dapagliflozin-prices-are-dropping<\/li>\n\n\n\n
      24. Oregon Division of Financial Regulation. “Prescription Drug Price Transparency FAQ.” https:\/\/dfr.oregon.gov\/drugtransparency\/pages\/faq.aspx<\/li>\n\n\n\n
      25. Federal Trade Commission. “FTC Renews Challenge of More Than 200 Improper Patent Listings.” May 21, 2025. https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2025\/05\/ftc-renews-challenge-more-200-improper-patent-listings<\/li>\n\n\n\n
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      29. Federal Trade Commission. “FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs.” April 30, 2024. https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2024\/04\/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma<\/li>\n\n\n\n
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      35. Abel + Imray. “Ozempic Patent Expiry: Have the Scales Finally Tipped?” https:\/\/www.abelimray.com\/resources\/newsletters\/ozempic-patent-expiry-have-the-scales-finally-tipped<\/li>\n\n\n\n
      36. ProActRx. “Novo Nordisk settles Ozempic patent case with Mylan.” October 2024. https:\/\/secure.proactrx.com\/resource\/news\/novo-nordisk-settles-ozempic-patent-case-with-mylan<\/li>\n\n\n\n
      37. DrugPatentWatch. “FARXIGA Patent Expiration and Exclusivity Data.” https:\/\/www.drugpatentwatch.com\/p\/tradename\/FARXIGA<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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